Senior Manager, Quality Assurance/Qualified Person
Amsterdam, Amsterdam, Netherlands
Full Time
Tech Ops
Experienced
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is seeking an experienced Clinical and Commercial Qualified Person (QP) who will play a key role in ensuring quality and regulatory compliance across the product lifecycle, including the manufacture, testing, certification, release, importation, distribution, and ongoing quality oversight of Investigational Medicinal Products (IMPs) used in global clinical trials and of commercial medicinal products supplied to patients.
The QP will serve as a key member of the Technical Operations GMP & GDP QA team and act as the QP named on Rhythm’s Manufacturer’s/Importer’s Authorization (MIA) responsible for certification and release of clinical trial materials and commercial medicinal products in accordance with Regulation (EU) No 536/2014, EU Directive 2001/83/EC, EU GMP Annex 16, applicable Marketing Authorizations and Clinical Trial Applications, and other applicable GMP and GDP requirements. The role will provide quality oversight across clinical and commercial supply chains, including contract manufacturers, packaging and labeling organizations, testing laboratories, depots, warehouses, and distribution partners.
The QP will report to the Senior Director, Head of Quality Assurance GMP, GDP, RP & DP and collaborate closely with Clinical Operations, Commercial, Regulatory Affairs, CMC, Supply Chain, Pharmacovigilance, Medical Affairs, and external partners globally.
Responsibilities and Duties
Qualifications and Skills
This role is based out of our corporate office in the Netherlands. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Netherlands office in coordination with their department and business needs.
More About Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare melanocortin-4 receptor (MC4R) pathway diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm Our Core Values Are
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is seeking an experienced Clinical and Commercial Qualified Person (QP) who will play a key role in ensuring quality and regulatory compliance across the product lifecycle, including the manufacture, testing, certification, release, importation, distribution, and ongoing quality oversight of Investigational Medicinal Products (IMPs) used in global clinical trials and of commercial medicinal products supplied to patients.
The QP will serve as a key member of the Technical Operations GMP & GDP QA team and act as the QP named on Rhythm’s Manufacturer’s/Importer’s Authorization (MIA) responsible for certification and release of clinical trial materials and commercial medicinal products in accordance with Regulation (EU) No 536/2014, EU Directive 2001/83/EC, EU GMP Annex 16, applicable Marketing Authorizations and Clinical Trial Applications, and other applicable GMP and GDP requirements. The role will provide quality oversight across clinical and commercial supply chains, including contract manufacturers, packaging and labeling organizations, testing laboratories, depots, warehouses, and distribution partners.
The QP will report to the Senior Director, Head of Quality Assurance GMP, GDP, RP & DP and collaborate closely with Clinical Operations, Commercial, Regulatory Affairs, CMC, Supply Chain, Pharmacovigilance, Medical Affairs, and external partners globally.
Responsibilities and Duties
- Serve as the designated Qualified Person for certification of Investigational Medicinal Products (IMPs) for use in EU and UK clinical trials and commercial medicinal products for supply to authorized markets, as applicable, exercising statutory independence in product release decisions.
- Prepare, review, and sign QP Declarations (QPDs) for IMPs in support of Clinical Trial Applications and substantial modifications across global trial sites.
- Ensure each IMP batch has been manufactured, tested, packaged, labeled, stored, and distributed in accordance with EU GMP, applicable Clinical Trial Regulations, and approved Clinical Trial Applications.
- Ensure each commercial batch has been manufactured and tested in accordance with EU GMP, EU GMP Annex 16, the applicable Marketing Authorization, product specifications, and approved manufacturing and testing arrangements.
- Perform QP certification of clinical batches, placebo materials, and commercial finished product batches, as applicable.
- Maintain oversight of clinical and commercial supply chains from drug substance through manufacture, packaging, labeling, storage, distribution, return, recall, and destruction activities.
- Provide Quality and QP oversight for clinical development, commercialization, product launch, and routine commercial supply activities, and provide GMP and GDP guidance to cross-functional stakeholders.
- Participate in investigations of deviations, complaints, temperature excursions, protocol-related quality events, out-of-specification results, and CAPAs associated with clinical trial materials and commercial products.
- Assess product quality defects, market complaints, recalls, and other reportable quality events, supporting timely escalation and Health Authority notification where required.
- Review and approve GMP documentation supporting clinical and commercial manufacturing activities, including batch records, validation documentation, specifications, stability protocols and reports, change controls, and quality agreements.
- Review Product Quality Reviews and other ongoing process and product performance data to support continued verification of commercial product quality and state of control.
- Lead or participate in qualification, auditing, and ongoing oversight of CMOs, packaging sites, contract laboratories, depots, warehouses, and distribution providers supporting clinical and commercial products.
- Review and approve technical and quality agreements with clinical and commercial service providers and manufacturing partners.
- Support inspection readiness activities and represent Quality Assurance and the QP function during Health Authority inspections, sponsor audits, partner audits, and internal audits.
- Contribute to the development, review, and approval of SOPs, policies, and work instructions related to GMP, GDP, QP certification, clinical trial supply, and commercial supply activities.
- Support new product introductions, technology transfers, process validation, investigational and commercial product lifecycle management, and expansion into additional clinical trial and commercial markets.
- Act as a Quality business partner to Clinical Development, Technical Operations, and Commercial teams and promote a culture of quality, compliance, and patient safety.
Qualifications and Skills
- Master’s degree in pharmacy, Industrial Pharmacy, Pharmaceutical Sciences, Biotechnology, Biochemistry, or a related life sciences discipline.
- Eligible and qualified to act as a Qualified Person under Article 49 of EU Directive 2001/83/EC.
- Minimum of 5 years of pharmaceutical industry experience in Quality Assurance, GMP compliance, manufacturing, clinical supply, or commercial supply operations with at least one (1) year of direct QP certification and batch release experience.
- Demonstrated experience supporting both Investigational Medicinal Products (IMPs) and commercial medicinal products, including QP certification or batch release activities within Europe.
- Thorough understanding of EU GMP requirements, including Annex 16, EU GDP, ICH guidelines, Clinical Trial Regulation (EU) No. 536/2014, and requirements applicable to authorized medicinal products.
- Experience overseeing clinical trial and commercial supply chains, including manufacture, packaging, labeling, testing, storage, and distribution.
- Experience managing contract manufacturing organizations, contract laboratories, depots, warehouses, and external GMP and GDP service providers.
- Strong knowledge of pharmaceutical quality systems, including deviations, CAPAs, change controls, risk management, validation, supplier qualification, complaints, recalls, Product Quality Reviews, and inspection management.
- Ability to make independent QP and quality decisions and exercise sound scientific and regulatory judgment.
- Excellent communication, collaboration, and stakeholder-management skills across clinical, technical, regulatory, supply chain, and commercial functions.
- Experience interacting with regulatory authorities and supporting inspections is highly desirable.
- Experience with QP certification of sterile products is preferred.
- Fluency in English is required; additional European languages are advantageous.
This role is based out of our corporate office in the Netherlands. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Netherlands office in coordination with their department and business needs.
More About Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare melanocortin-4 receptor (MC4R) pathway diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm Our Core Values Are
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
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